Does laryngeal reinnervation or type I thyroplasty give better voice results for patients with unilateral vocal fold paralysis (VOCALIST): study protocol for a feasibility randomised controlled trial

Abstract

IntroductionA functioning voice is essential for normal human communication. A good voice requires two moving vocal folds; if one fold is paralysed (unilateral vocal fold paralysis (UVFP)) people suffer from a breathy, weak voice that tires easily and is unable to function normally. UVFP can also result in choking and breathlessness. Current treatment for adults with UVFP is speech therapy to stimulate recovery of vocal fold (VF) motion or function and/or injection of the paralysed VF with a material to move it into a more favourable position for the functioning VF to close against. When these therapies are unsuccessful, or only provide temporary relief, surgery is offered. Two available surgical techniques are: (1) surgical medialisation; placing an implant near the paralysed VF to move it to the middle (thyroplasty) and/or repositioning the cartilage (arytenoid adduction) or (2) restoring the nerve supply to the VF (laryngeal reinnervation). Currently there is limited evidence to determine which surgery should be offered to adults with UVFP.Methods and analysisA feasibility study to test the practicality of running a multicentre, randomised clinical trial of surgery for UVFP, including: (1) a qualitative study to understand the recruitment process and how it operates in clinical centres and (2) a small randomised trial of 30 participants recruited at 3 UK sites comparing non-selective laryngeal reinnervation to type I thyroplasty. Participants will be followed up for 12 months. The primary outcome focuses on recruitment and retention, with secondary outcomes covering voice, swallowing and quality of life.Ethics and disseminationEthical approval was received from National Research Ethics Service—Committee Bromley (reference 11/LO/0583). In addition to dissemination of results through presentation and publication of peer-reviewed articles, results will be shared with key clinician and patient groups required to develop the future large-scale randomised controlled trial.Trial registration numberISRCTN90201732; 16 December 2015.

Conservative treatment for uncomplicated appendicitis in children: the CONTRACT feasibility study, including feasibility RCT

“…The CONTRACT communication study is one of a relatively small number of qualitative substudies to have been embedded within a feasibility trial with the aim of optimising recruitment and informing a future definitive trial. [55][56][57][58] Uniquely, our study drew on trial recruitment consultation audio-recordings, interviews with health professionals, children (patients) and parents. Although studies of this sort have been advocated, 38 embedded qualitative studies rarely include the perspectives of both children and their parents.…”

Nonselective Reinnervation as a Primary or Salvage Treatment of Unilateral Vocal Fold Palsy

“…We attribute the long‐term stability of voice quality to restoration and preservation of laryngeal muscle innervation preventing muscular atrophy. To further affirm our experience concerning better voice results after ULR than after thyroplasty, a direct comparison study needs to be implemented as suggested by Blackshaw et al…”

Multi‐institutional Evaluation of Medialization Laryngoplasty in the Elderly

“…Therapy is sometimes used preoperatively to minimize laryngeal hyperfunction and help improve voice outcomes postoperatively, despite a lack of evidence regarding the combined voice therapy and surgical approach to glottic insufficiency. [21][22][23] This study provides some evidence that this approach may not be necessary, although it is recognized that a lack of consistency in content, frequency, and type of voice therapy in treatment of glottic insufficiency renders comparison among treatment combinations difficult.…”